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Evaluation of the High Frequency Digit Triplet test in Cystic Fibrosis

Details

Therapeutic category
The type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Other

Trial status

Open

Phase
The different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

Not Applicable

Full title

Evaluation of the High Frequency Digit Triplet test in Cystic Fibrosis (HFDT-CF)

The purpose of this study is to find out whether the High Frequency Digit Triplet test can be used to screen patients with cystic fibrosis for hearing loss in conditions of health and pulmonary exacerbation. It is also designed to find out the youngest age at which a child can perform the test, the prevalence of hearing loss in a CF population and the prevalence of genetic mutations known to be associated with hearing loss in the same population

Trial type

Non-medication

Length of participation
The length of time a participant will take part in a trial, from the first to the last appointment

1 day

Intervention
The name of the treatment or therapy being researched

High Frequency Digit Triplet test

Recruitment target
The number of participants who need to be recruited for the trial in the UK

388

Last edited date

25 August 2017

Sponsor

University of Nottingham

Sponsor type

Academic

Who can take part?

Top inclusion criteria
  • A diagnosis of CF, confirmed by genotype or sweat test, with characteristic clinical features.
  • Aged 5years and over
Top exclusion criteria
  • None. In individuals with a hearing aid, we will perform PTA and HFDT tests without the aid.
  • Individuals found to have conductive deafness after randomisation will be fully assessed for this prior to continuing with the study.

CF centres running this trial

Recruiting

Birmingham Children's Hospital NHS Foundation Trust

Address

Steelhouse Lane Birmingham West Midlands B4 6NH

Recruitment starts

January 2015

Recruitment ends

July 2018

Contact

Clarke, Jane Rebecca

Get in touch

Recruiting

Heart of England NHS Foundation Trust

Address

Birmingham Heartlands Hospital Bordesley Green East Birmingham West Midlands B9 5SS

Recruitment starts

February 2015

Recruitment ends

July 2018

Contact

Nash, Edward

Get in touch

Recruiting

Nottingham University Hospitals NHS Trust

Address

Trust Headquarters City Hospital campus Hucknall Road Nottingham Nottinghamshire NG7 2UH

Recruitment starts

January 2015

Recruitment ends

July 2018

Contact

Smyth, Alan

Get in touch